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TAMOXIPLEX
is effective in the treatment of metastatic
breast
cancer
in women and men. In premenopausal women with metastatic breast cancer, TAMOXIPLEX is an alternative to
oophorectomy or
ovarian
irradiation
. Available evidence indicates that patients whose tumors are
estrogen
receptor
positive are more likely to benefit from TAMOXIPLEX
therapy
.
Adjuvant
Treatment of Breast Cancer
TAMOXIPLEX is indicated for the treatment of node-positive breast cancer in women following total
mastectomy
or segmental mastectomy,
axillary dissection
, and breast irradiation. In some TAMOXIPLEX adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive
axillary
nodes.
TAMOXIPLEX is indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary
dissection
, and breast irradiation.
The estrogen and
progesterone
receptor values may help to predict whether adjuvant TAMOXIPLEX therapy is likely to be beneficial.
TAMOXIPLEX reduces the occurrence of
contralateral
breast cancer in patients receiving adjuvant TAMOXIPLEX therapy for breast cancer.
Ductal Carcinoma in Situ
(
DCIS
)
In women with DCIS, following breast
surgery
and
radiation
, TAMOXIPLEX is indicated to reduce the risk of invasive breast cancer (see
BOXED WARNING
at the beginning of the label). The decision regarding therapy with TAMOXIPLEX for the reduction in breast cancer
incidence
should be based upon an individual assessment of the benefits and risks of TAMOXIPLEX therapy.
Current data from
clinical trials
support five years of adjuvant TAMOXIPLEX therapy for patients with breast cancer.
Reduction in Breast Cancer Incidence in High Risk Women
TAMOXIPLEX is indicated to reduce the incidence of breast cancer in women at high risk for breast cancer. This effect was shown in a study of 5 years planned duration with a
median
follow-up of 4.2 years. Twenty-five percent of the participants received drug for 5 years. The longer-term effects are not known. In this study, there was no impact of
tamoxifen
on overall or breast cancer-related
mortality
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